Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients
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Purpose
The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections HIV-Associated Lipodystrophy Syndrome |
Drug: non-nucleoside reverse transcriptase inhibitors Drug: nucleoside reverse transcriptase inhibitors Drug: protease inhibitor |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Comparative Study Evaluating the Rate of Occurrence of a Lipoatrophy Syndrome in ARVnaive HIV-1 Infected Patients Receiving NRTI-Sparing Antiretroviral Regimen (Hippocampe - ANRS 121) |
- Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
- During the study until 96 weeks
- Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml
- Evolution of viral load
- Evolution of CD4 lymphocytes
- Evaluation of clinical safety
- Evaluation of lipohypertrophic syndrome
- Evaluation of glucidic and lipids metabolic profile
- Evaluation of mitochondrial toxicity
- Evaluation of bone toxicity by measurement of bone density
- Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors
- Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors
- Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)
| Estimated Enrollment: | 112 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | July 2005 |
The study compare the rate of occurrence of lipoatrophy in ARVnaive HIV-1 infected patients receiving either a NRTI-sparing antiretroviral therapy with NRTI and boosted PI,or a standard antiretroviral therapy with 2 NRTI plus PI or NNRTI.
Patients were randomized (2:1:1) to either PI+NNRTI (Gp1) or standard therapy, 2NRTI+ either PI (Gp2) or + NNRTI (Gp3). The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.
Lipoatrophy is evaluated by evolution of subcutaneous fat in the limbs measured by DEXA (Dual Energy X-ray Absorptiometry)and CT-scan of the thighs between baseline and W96.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed HIV-1-infected diagnosis
- Naive of antiretroviral treatment
- Plasma viral load (VL) over 5000 copies/ ml
- CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml
- Written, informed consent after approval by the local human research ethics committee
Exclusion Criteria:
- Acute opportunistic infection
- Pregnancy or breast feeding
- Cytotoxic systemic chemotherapy except for Kaposi sarcoma
- Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study
- Polynuclear neutrophils below 750/mm3
- Hemoglobin below 8 g/dl
Platelets below 20 000/mm3
- Creatinine level over 1.5 (upper normal) UN
- ASAT, ALAT, bilirubin level over 3 UN
Contacts and Locations| France | |
| Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere | |
| Paris, France, 75013 | |
| Principal Investigator: | Claudine Duvivier, MD | Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris |
| Study Chair: | Dominique Costagliola | INSERM U 720 |
More Information
No publications provided by French National Agency for Research on AIDS and Viral Hepatitis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00122668 History of Changes |
| Other Study ID Numbers: | ANRS121 HIPPOCAMPE |
| Study First Received: | July 21, 2005 |
| Last Updated: | November 14, 2005 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV Protease Inhibitors HIV-Associated Lipodystrophy Syndrome HIV infections |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy HIV-Associated Lipodystrophy Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic Skin Diseases |
Lipid Metabolism Disorders Metabolic Diseases Protease Inhibitors HIV Protease Inhibitors Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on March 07, 2013
